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Updated: Jul 16, 2026

The WATCHMAN Left Atrial Appendage Closure Device for Atrial Fibrillation
Published on: February 28, 2012
Left atrial appendage occlusion for patients with valvular diseases without atrial fibrillation (the OPINION Study):
Fan Ju1, Xin Yuan1, Hansong Sun2
1Department of Cardiac Surgery, Chinese Academy of Medical Sciences & Peking Union Medical College Fuwai Hospital, Xicheng District, Beijing, China.
Insights
Surgical left atrial appendage occlusion (SLAAO) during valve surgery may prevent long-term stroke in patients without atrial fibrillation (AF). This trial investigates SLAAO
Area of Science:
- Cardiovascular Surgery
- Neurology
- Clinical Trials
Background:
- Atrial fibrillation (AF) is a major cause of perioperative stroke in aortic and mitral valve surgery.
- Previous studies on surgical left atrial appendage occlusion (SLAAO) are retrospective and may have confounding factors.
- Opportunistic SLAAO during cardiac surgery is being investigated for stroke prevention in specific patient groups.
Purpose of the Study:
- To test the hypothesis that opportunistic SLAAO can prevent long-term stroke after cardiac surgery.
- To evaluate the efficacy of SLAAO in patients undergoing mitral or aortic valve surgery without a history of AF and with a CHA2DS2-VASc score of 2 or higher.
- To assess the impact of SLAAO on stroke and cardiovascular mortality.
Main Methods:
- A single-blinded, multicentre, randomised controlled trial involving 2118 patients.
- Patients undergoing aortic or mitral surgery without AF will be randomized 1:1 to intervention (SLAAO) or control groups.
- The primary outcome is a composite of new ischemic stroke, transient ischemic attack, and cardiovascular mortality over 1 year.
Main Results:
- This section is to be filled once the trial results are available.
- The study is currently recruiting patients and has not yet produced results.
- Data collection and analysis will occur post-completion of patient follow-up.
Conclusions:
- This trial will provide crucial data on the effectiveness of SLAAO in preventing stroke in a high-risk surgical population.
- Findings will inform clinical practice regarding the prophylactic use of SLAAO during valve surgery.
- The study aims to reduce the incidence of stroke and improve long-term outcomes for cardiac surgery patients.
Introduction:
Atrial fibrillation (AF) is a significant cause of perioperative stroke in aortic and mitral valve surgeries. Although several large studies have evaluated surgical left atrial appendage occlusion (SLAAO) during cardiac surgeries, their retrospective nature and an uncontrolled broad spectrum of conditions leave them subject to potential residual confounding. This trial aims to test the hypothesis that opportunistic SLAAO can prevent long-term stroke after cardiac surgery in patients receiving mitral or aortic valve surgeries without a history of AF and with a CHA2DS2-VASc score of 2 or higher.
Methods And Design:
This study is a single-blinded, multicentre, randomised controlled trial. A total of 2118 patients planning to undergo aortic or mitral surgery without AF will be recruited and equally randomised into intervention or control arms at a 1:1 ratio. In the intervention arm, suture excision of the left atrial appendage (LAA) will be performed during the operation in addition to the original surgery plan. In the control arm, the operation will be performed according to the surgery plan without any intervention on the LAA. The primary outcome is a composite of newly occurred ischaemic stroke or transient ischaemic attack and cardiovascular mortality during a 1-year follow-up. Secondary outcomes include postoperative AF, cardiovascular mortality, newly occurred ischaemic stroke, newly occurred transient ischaemic attack, newly occurred haemorrhagic stroke, bleeding events, and AF-associated health utilisation.
Ethics And Dissemination:
The Ethics Committee in Fuwai Hospital approved this study. Patients will give informed consent to the study. An information leaflet will be provided to participating patients to introduce the SLAAO procedure. Patients and the public will not get involved in developing the research hypothesis, study design or any other part of this protocol. We plan to publish several papers in peer-reviewed journals about the current research and these will include a description of the study's development and the main findings of the study.
Trial Registration Number:
ChiCTR2100042238.
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